Spots Global Cancer Trial Database for Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

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Trial Identification

Brief Title: Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

Official Title: Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia

Study ID: NCT00017589

Conditions

Leukemia

Interventions

oblimersen sodium

gemtuzumab ozogamicin

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.

Detailed Description: OBJECTIVES: * Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin. * Determine the overall response rate and duration of response of patients treated with this regimen. * Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.